With the development of surgical techniques, adjuvant therapy and neoadjuvant therapy, the survival time of rectal cancer patients after surgery has been significantly improved, but organ dysfunction is still an important problem affecting the quality of life of patients after surgery. With the continuous deepening of clinical research and practice and the updating of relevant theories, more detailed and reliable evidence-based medical evidence has been accumulated in the field of pelvic organ function protection in rectal cancer surgery, and has been continuously verified in the clinical real world at home and abroad. In order to further improve the awareness of domestic physicians on the protection of organ function during the treatment of rectal cancer, standardize the evaluation methods and surgical methods, reduce the incidence of organ dysfunction, and thus improve the quality of life of patients, Society of Colon & Rectal Surgeons of Chinese College of Surgeons of Chinese Medical Doctor Association, Section of Colorectal Surgery of Branch of Surgery of Chinese Medical Association, National Health Commission Capacity Building and Continuing Education Center Colorectal Surgery Committee, and Colorectal and Anal Function Surgeons Committee of China Sexology Association organized the discussion among relevant experts. On the basis of the 2021 edition of the Chinese Expert Consensus on the Protection of Pelvic Organ Function in Rectal Cancer Surgery, the recent evidence-based medical evidence was analyzed and summarized, and the definition, risk factors, evaluation methods, prevention and other issues of organ dysfunction after rectal cancer surgery were analyzed with reference to relevant domestic and foreign studies and combined with clinical practice. Proposed the diagnosis, evaluation and treatment of pelvic organ dysfunction in rectal cancer surgery, and finally formed the "Chinese expert Consensus on the protection of pelvic organ function in rectal cancer surgery (version 2025)".
Humans ; Rectal Neoplasms/surgery* ; Consensus ; Pelvis/physiopathology* ; Quality of Life ; Postoperative Complications/prevention & control*

On March 19, 2021, the National Medical Products Administration(NMPA) issued the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council of the People's Republic of China), which clearly stipulated in Article 53 the basic definition and scope of use of in vitro diagnostic reagents developed by medical institutions. It also pointed out that the relevant administrative measures shall be formulated by the Drug Regulatory Department of the State Council in conjunction with the Health Department of the State Council. This initiative marks the re-incorporation of in vitro diagnostic reagents developed by medical institutions into China's regulatory system. This study reviewed the development of regulatory policies for self-developed in vitro diagnostic reagents at home and abroad, combined with the Key Points of On-site Verification of Self-developed In Vitro Diagnostic Reagents in Shanghai Medical Institutions issued by the Shanghai Municipal Drug Administration, in conjunction with the Shanghai Municipal Health Commission, and the specific verification work of pre-record evaluation, and sorted out the general requirements for the quality management system of self-developed in vitro diagnostic reagents. The purpose is to provide some references for the further development of this pilot work and its nationwide promotion.
China ; Quality Control ; Indicators and Reagents/standards* ; Reagent Kits, Diagnostic/standards*

Point-of-care testing (POCT), as an emerging diagnostic technology, is gradually becoming an important part of the clinical diagnostic field due to its advantages, such as ease of operation, rapid response, and portability. This paper primarily introduces two mainstream technologies in POCT: lateral flow assays and nucleic acid amplification. It covers the basic principles, applications, and quality control points in design and development of the two mainstream technologies, aiming to provide a technical reference for device manufacturers, researchers, and regulatory agencies.
Point-of-Care Testing ; Point-of-Care Systems ; Quality Control ; Equipment Design ; Nucleic Acid Amplification Techniques ; Humans

In order to track the running status of the accelerator in real time, discover potential problems in time, reduce the failure rate, and ensure the safety of radiotherapy patients, a linear accelerator quality management monitoring system is designed based on log files. The system adopts B/S architecture, with the server written in Python3.7 language, and is built based on Django2.2.7 framework. The system uses Python3.7 and Pylinac packages to analyze the log files of each plan, obtaining the planned beam quantity, flux gamma pass rate, and position information of multileaf collimator, etc., to realize the quality monitoring of medical linear accelerator, and customize the development of accelerator spare parts and maintenance management modules. According to statistics, after the establishment of the quality management monitoring system, the accelerator has achieved a 16% reduction in failure rate and a 30% reduction in the downtime rate, which ensures its stable operation in clinical settings.
Particle Accelerators ; Quality Control ; Software

As a new type of high-risk packaging container, prefilled syringes are more widely used, and concerns regarding their effectiveness, stability and safety in clinical use have become prominent increasingly. However, the leachable substances from prefilled syringes may cause harm to humans in different degrees. Therefore, this paper reviews the research progress of leachable substances in prefilled syringes, which is not only of great significance for the quality control of prefilled syringe products, but also contributes to the healthy development of the industry.
Syringes ; Drug Packaging ; Quality Control

From the perspective of performance evaluation, this paper describes briefly the concerns of study on each component module and the entire instrument, clinical items, software, and product testing on droplet digital PCR instruments, including the study methods and quality control requirements. The increase of the research and development efficiency of products and contribute to the promotion of application of digital PCR instruments in clinical laboratories are expected.
Polymerase Chain Reaction/methods* ; Quality Control ; Software ; Humans

Due to the wide variety and varying quality of medical wound dressings, as well as the current lack of unified national or industry standards for regulation, this paper proposes a research strategy for establishing a quality evaluation system for medical wound dressings‌. By developing a technical roadmap, this strategy clarifies the process flow and key points in the quality evaluation process, establishes evaluation methods for various types of medical wound dressings, and addresses important issues such as how to determine key performance indicators based on product characteristics and how to research and validate test methods for key items. This provides a detailed and feasible research strategy and evaluation method for medical wound dressing manufacturers, testing institutions, and regulatory authorities. It reduces the difficulty and cost of quality evaluation for medical wound dressings and has certain significance in standardizing and improving their quality level, ensuring their safety and effectiveness, and serving the quality and safety regulation of medical devices.‌.
Bandages/standards* ; Quality Control ; Humans ; Wounds and Injuries/therapy*

OBJECTIVE: To investigate the transfusion and infusion warmer manufacturers, combine the use failures to analyze adverse events, and provide support for enterprise risk management and clinical safe use. METHODS: The sentinels from 7 manufacturing enterprises and 11 medical institutions that participated in Shandong Province's key monitoring program during the "14th Five-Year Plan" period were targeted. This was done by understanding the equipment's principles, structures, and quality control. Additionally, real-world data from January 2019 to December 2023 were collected to count adverse events. RESULTS: During production, there are risks in switching power supply stability and solder joint firmness. Fifteen kinds of faults occurred during use, and common faults such as inability to heat, unable to turn on the machine, and bubbles in the infusion tube accounted for more than 80%. CONCLUSION There are many risk points and failures for transfusion and infusion warmers, so enterprises should improve processes and quality control to address risks, and medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.
Blood Transfusion/instrumentation* ; Risk Factors ; Quality Control ; Humans ; Risk Management ; Equipment Failure

Multimorbidity of chronic diseases is one of the most common health issues among older adults, and the resulting demand for long-term medical care and management imposes a considerable burden on healthcare systems. Muscle strength, a core indicator of overall health status, is closely associated with the risk of developing multimorbidity of chronic diseases in older adults. Decline in muscle strength not only increases the risk of multimorbidity of chronic diseases but also interacts with it to exacerbate disease burden. In older adults with existing multimorbidity of chronic diseases, muscle strength decline can impair physical function and quality of life, leading to a vicious cycle of disease progression and physical disability. Strength training can help prevent multimorbidity, with potential mechanisms including the promotion of anti-inflammatory effects and enhancement of mitochondrial energy metabolism. This review summarizes the impact of muscle strength decline on multimorbidity of chronic diseases in older adults and the effectiveness and potential mechanisms of exercise interventions, providing evidence to delay muscle strength decline, prevent the occurrence and progression of multimorbidity of chronic diseases, and improve quality of life in older adults.
Humans ; Aged ; Chronic Disease/prevention & control* ; Muscle Strength/physiology* ; Multimorbidity ; Quality of Life ; Resistance Training ; Exercise Therapy ; Exercise ; Sarcopenia

OBJECTIVES: To construct a GA-BP neural network model based on the spectrum-effect relationship of Cassia seeds extract and test its performance for quality control of Cassia seeds using spectrum-effect score. METHODS: The HPLC fingerprints of Cassia seeds extract (0.1, 0.2, and 0.4 g/mL) were established. In a mouse model of 5-Fu-induced liver injury treated with 0.4, 0.8, and 1.6 g/kg of Cassia seeds extract, the pharmacodynamics parameters were measured to calculate the comprehensive efficacy using AHP-EWM. A GA-BP neural network model between the fingerprints and comprehensive efficacy was constructed, and the corresponding predicted comprehensive efficacy was obtained. The spectrum-effect relationship between the fingerprints and the measured and predicted comprehensive efficacy was established using grey correlation method followed by Gaussian fitting analysis. The spectral efficiency score was calculated using the relative peak area of the fingerprints and the correlation degree of the spectral efficiency. The reliability of the data was tested using the Z-ratio score method. The limit range of the spectral efficiency score was determined and the quality of the verification samples was evaluated. RESULTS: The error between the predicted value using the GA-BP neural network model and the measured value of the comprehensive efficacy was less than 0.2. Gaussian fitting analysis showed good fitting between the spectrum-effect relationship data of the measured and predicted comprehensive efficacy. The limit of the spectral efficiency score was 6.16-7.30. The prediction results for each verification group were consistent with the experimental results and within the limit of spectral efficiency score, and the results of Z-ratio score analysis demonstrated good data reliability. CONCLUSIONS The GA-BP neural network model can effectively predict the comprehensive efficacy of Cassia seeds extract, and the established spectrum-effect scoring method can be used for quality evaluation of samples.
Neural Networks, Computer ; Animals ; Seeds/chemistry* ; Mice ; Cassia/chemistry* ; Quality Control ; Drugs, Chinese Herbal/pharmacology* ; Plant Extracts/pharmacology* ; Male